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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K041563
Device Name OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
Applicant
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
1500 LITTLETON RD.
PARSIPPANY,  NJ  07054
Applicant Contact ANTHONY G AMITRANO
Correspondent
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
1500 LITTLETON RD.
PARSIPPANY,  NJ  07054
Correspondent Contact ANTHONY G AMITRANO
Classification Product Code
LFD  
Date Received06/10/2004
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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